Women’s views and experiences of augmentation of labour with synthetic oxytocin infusion. A protocol for a qualitative evidence synthesis.

Background: Augmentation of labour (AOL) is the most common intervention to treat labour dystocia. Previous research reported extensive disparities in AOL rates across countries and institutions. Despite its widespread use, women’s views on and experiences of intrapartum augmentation with infused synthetic oxytocin are limited. Methods: A qualitative evidence synthesis on women’s views and experiences of AOL with synthetic oxytocin after spontaneous onset of labour will be conducted. Qualitative studies and studies employing a mixed methods design, where qualitative data can be extracted separately, will be included, as will surveys with open-ended questions that provide qualitative data. A systematic search will be performed of the databases: MEDLINE, CINAHL, EMBASE, PsycINFO, Maternity and Infant Care and Web of Science Core Collection from the date of inception. The methodological quality of included studies will be assessed using the Evidence for Policy and Practice Information and Co-ordinating Centre’s appraisal tool. A three-stage approach, coding of data from primary studies, development of descriptive themes and generation of analytical themes, will be used to synthesise findings. Confidence in findings will be established by the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research. Discussion: This qualitative evidence synthesis may provide valuable information on women’s experiences of AOL and contribute to a review of clinical practice guidelines for maternity care providers. PROSPERO registration: CRD42021285252 (14/11/2021)


analysis" OR
"discourse analysis" OR "action research" OR "participatory research" OR "constant comparative method" OR "mixed model" OR "mixed method*" OR "mixed design*" OR "multiple method*" OR multimethod author (DOM and DD).Subsequently, similarities and differences will be identified, and codes will be grouped into descriptive categories and, through their further interpretation, reflection and discussion within the review team analytical themes will be generated.


Assessing confidence in the findings

The level of confidence in the review findings will be established using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) (Booth et al., 2018;Colvin et al., 2018;Glenton et al., 2018;Lewin et al., 2018a;Lewin et al., 2018b;Munthe-Kaas et al., 2018;Noyes et al., 2018).GRADE-CERQual assesses, individually, every distinct review finding according to its four components: the methodological limitations, coherence, extant or adequacy of contributing data, and elevancy to the review question.Then, an overall assessment of confidence in each finding is categorised as high, moderate, low, or very low confidence (Table 3).Findings will be deemed to be of 'high confidence' at the outset and will be downgraded accordingly if there are concerns regarding any of the GRADE-CERQual components.Following the GRADE-CERQual recommendations, this process will be performed independently by two reviewers (SAP and DOM), facilitating opportunities for reflection and discussion within the review team (Lewin et al., 2018a).


Study status

A total of 9306 articles were retrieved and title and abstract screening is in progress.The review will be finished in February 2022.


E -Adequately described the data analysis methods

There was good or some attempt to establish the:


Discussion

This QES will be the first to date to synthesise qualitative research o women's views and experiences of AOL with synthetic oxytocin after spontaneous onset of labour.Due to the frequency with which AOL is carried out in modern maternity care, it is vital that midwives, obstetricians, and policy makers have a clear understanding of how women experience this intervention.The findings of this review will provide a deeper insight into the current gaps in clinical practice.This evidence will potentially support the development of new strategies to improve women's care into the future.

We will disseminate the findings of this QES through publication in a peer-reviewed journal that predominantly publishes maternity care research and through academic conference presentations.Social media posts (e.g.Instagram and Twitter) will be also employed as part of the dissemination strategy.
Reflexivity statement

In accordance with rigour in qualitative research, it is important that the authors discuss how their background or expertise may have influenced the interpretation of the findings (Barrett et al., 2020) This project contains the following extended data: Appendix 1: Data.Extraction.Form.Excel.


Reporting guidelines

Open Science Framework: PRISMA-P Checklist for 'Women's views and experiences of augmentation of labour with synthetic oxytocin infusion.A protocol for a qualitative eviden

: https://doi.org/1
.17605/OSF.IO/2QYJC.

of thought that the review team might consider:

In the Introduction interesting information is provided in relation to the AOL ranges, variation across crite ia, services etc. have the team considered how these variations may impact on their synthesis?


○

In the assessment of methodological qu lity have the team considered how they will interpret Criteria R,G,H and I, given that the prompts of the criteria speak to reliability and validity?


○

The extraction of the "findings" -the team should indicate if they will include findings from findi gs / results sections of included studies, from discussion section or both?

○ I suggest that it is important that the team include a reflexive section in their protocol to highlight how their professional and research backgrounds will influence their engagement with all methods of this QES.


○

Is the rationale for, and objectives of, he study clearly described?Yes


Is the study design appropriate for the research question? Yes

Are sufficien details of the methods provided to allow replication by others?Yes


Are the d tasets clearly presented in a useable and accessible format? Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: My research areas of interest lie in all aspects of midwifery an

maternity care.My methodol
gical areas of expertise are qualitative research methodologies and methods including qualitative evidence synthesis.

I confirm that I have read this submission an believe that I have an appropriate level of expertise to confir th t it is of an acceptable scientific standard.

Response: Our QES have included 25 studies providing qualitative data on women's views and experiences of AOL with synthetic oxytocin infusion from 14 different countries.Of these, some have high AOL rates, others not.This has emerged in our preliminary findings.For example, some women expected to be augmented during labou , while others did not anticipate an AOL and did not read/seek information about it.We feel that the large and varied dataset will ensure that variation rates of AOL will not negatively impact on our QES.Furthermore, assessing the quality of our review findings using CERQual and, in particular, the 'adequacy and relevance' components will further address any concern about variations in prevalence of AOL in different jurisdictions.


○

In the assessment of methodological quality have the team considered how they will interpret Criteria R,G,H and I, given that the prompts of the criteria speak to reliability and validity?

○ Response: Regarding the methodological quality appraisal, we agreed to use the different criteria as explained in the original article (Thomas et al. 2003).For example, regarding the "Reliability of the data collection tools" (F), we considered they met the criteria if the authors used a topic guide or they provided examples of the topics addressed during the interviews.For "Validity of the data collection tools" (G),

ny type of recording was considered s
fficient.Regarding "Reliability of the data analysis" (H), we considered the criteria met if the more than one author participated in the data analysis and/or if the authors contacted an additional person with qualitative expertise to review the data analysis.We also considered the amount of data provided to support their findings.Regarding "Validity of the data analysis" (I), the criteria was met if the authors conducted negative cases analysis and/or member checking of the preliminary findings.


○

The extraction of the "findings" -the team should indicate if they will include findings from findings / results sections of included studies, from discussion section or both?

○ Response: We have included data from both results and discussion sections.Added: 'Regarding the findings, data from both, the results and discussion sections will be included'.

○ I suggest that it is important that the team include a reflexive section in their protocol to highlight how their professional and research backgrounds will influence their engagement with all methods of this QES.



* OR "open-ended question*" OR "open-ended survey*" OR "open-ended interview*") OR (experien* OR view* OR percept* OR perceiv* OR attitud* OR believ* OR belief* OR perspective* OR opinion* OR express* OR thought* OR think* OR feel* OR reaction* OR emotion* OR comprehen* OR understand* OR stance* OR "personal valu*" OR awar* OR approach* OR "self report*" OR self-report* OR emote*)Research typePublishe studies in English OR Spanish language


F-

Reliability of the data collection tools G -Validity of the data collection tools H -Reliability of the data analysis I -Validity of the data analysis Quality of the methods J -Used the appropriate data collection methods to allow for expression of views K -Used the appropriate methods for ensuring the analysis was grounded in the views L -Actively involved the participants in the design and conduct of the study


Any further responses from the reviewers can be found at the end of the article
and adapted for each database (Table 1). The databases to besearched are MEDLINE, CINAHL, EMBASE, PsycINFO,Maternity and Infant Care and Web of Science Core Collection.We will expand our search by additionally searching the greyliterature in thesis repositories (EThOS and DART-Europe)and the WHO International Clinical Tria

Registry Platform.(Int
oduction)2.The databases searched to source grey literaturehave been added (EThOS, DART-Europe, and the WHOInternational Clinical Trials Registry Platform) (Searchstrategy and study selection).3.We have clarified that the data from the incl

entation of th
phenomenon of interestLowIt is possible that the review finding is a reasonable representation of the phenomenon of interestVery lowIt is not clear whether the review finding is a reasonable representation of the phenomenon of interest

Table 2 . Criteria for methodological quality assessment (Thomas et al., 2003) 2
Quality of study reportingA -Aims and objectives clearly reported B -Adequately described the context of the research C -Adequately described the sample & sampling methods D -Adequately described the data collection methods




. SAP is a PhD student with a clinical background in midwifery.She became interested in AOL while working in acute maternity settings, where she observed and performed this intervention.Augmentation of labour has become her PhD topic.
oxytocin during labour. She led a multinational study that high-lighted the variations in the regimens and dosages on syntheticoxytocin use.Extended dataOpen Science Framework: Women's views and experiencesof augmentation of labour with synthetic oxytocin. A protocolfor a qualitative evidence synthesis, https://doi.org/10.17605/DOM, Lecturer in Midwifery, is a general nurse, midwife andclinical midwife teacher. DOM has experience in both quan-titative and qualitative methodologies, including expertise inQES.DD is an Associate Professor in Midwifery. Her areas of meth-odological research expertise include cohort studies, mixedmethods studies, qualitative research, and randomised

rials.DD has
onducted previous research on the use of synthetic
OSF.IO/2QYJC (Alòs-Pereñíguez et al., 2021).


the rationale for, and objectives of, the study clearly described? Yes Is the study design app

priate for the research questio
? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clea

y present
d in a useable and accessible format? with

No competing interests were disclosed.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly ci

d.College London, London, UK Thank you for giving me the opportunit
to review this timely and important qualitative systematic review regarding women's experiences of AOL.It is a very exciting piece of work and I look forward

o reading the findings.Need some further acknowled
ement/discussion around the huge variation of rat s of AOL, why this might be, what does the literature say?That you are focusing on spontaneous labor, this is very import

t to consider.Birth setting/plann
d place of birth and where labor is mostly experienced for example will influence the rates of synthesis.Perhaps a minor mention of non-pharma methods e.g.water immersion reduces transfer

ortunity to
critique these statistics.Not convinced this tool is appropriate for qualitative papers, much debate out there appraising quality in qualitative reviews but I personally agree it should be done.However, this tool reads as a quant tool-reliability/validity are positivist terms, you want to look for trustworthiness.Strongly suggest changing this.negative childbirth experiences are more vulnerable to developing serious mental health issues, including posttraumatic stress disorder (Ertan et al. 2021)'Search strategy: What sort of grey literature, be specific.Added: 'We will expand our sear h by additionally searching the grey literature in thesis repositories (EThOS and DART-Europe) and the WHO International Clinical Trials Registry Platform.The reference lists of studies identified for inclusion will also be reviewed'.Quality appraisal: Not convinced this tool is appropriate for quali

tive papers, much deba
e out there appraising quality in qualitative reviews but I personally agree it should be done.However, this tool reads as a quant tool-reliability/validity are positivist terms, you want to look for trustworthiness.Strongly suggest changing this.Although the terms reliability and validity may be considered as quantitative terms, Evidence for Policy and Practice Information (EPPI) and Coordinating Centre's appraisal tool was designed sp cifically for synthesising qualitative studies (Thomas et al. 2003).It assesses the studies through 12 criteria and has been successfully used in previous QES on maternal health (Panda t al. 2018, Smith et al. 2021a, Smith et al. 2021b)
Claire FeeleyKing'sReviewer Report 31 January 2022
○Response: Added.Please, refer to section "Reflexivity statement".○CompetingInterests:https://doi.org/10.21956/hrbopenres.14678.r31296© 2022 Feeley C. Some minor but important comments: Introduction: Wouldn't agree 'traditionally' is the right term, maybe typically?Although in t e US they are known for AOL with membranes intact...! ○ ○ Negative experiences may also mean traumatic experiences/PTSD a point that asserts the importance of getting labor care right so would add this in.(It also influences women to opt out of maternity care altogether, a key point for maternity services to consider).○ ○ Search strategy: What sort of grey literature, be specific.○ Quality appraisal: ○ Is ○ Response: ○ ○ Response: ○ Competing Interests: No competing interests were disclosed.

Acknowledging that the findings of this QES will be the res

rch teams' interpr
tation, several procedures will be put into practice to ensure trustworthiness, i.e two independent coders, keeping a research diary which will document thoughts and direction from the beginning of the process of undertaking the QES, and frequent discussions within the research team to agree evolvement of descriptive themes to analytical themes.To add to the transparency of the analytic process, quotations from the primary studies to support the results will be provided.CRD42021285252 (14/11/2021D

de
lying dataNo data are associated with this article.Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).Silvia Alòs-Pereñíguez holds a PhD scholarship, awarded in 2021, from the School of Nursing and Midwifery, Trinity College DublinThe funders had no role in study design, data collection and analysis, decision to publish, or preparat

ocol and giving us some comments and suggestions that will add to the quality of th
s QES.We have addressed each comment in the table below and highlighted cha ges in the text of the manuscript.In the Introduction intere ting information is provided in relation to the AOL ranges, variation across criteria, services etc. have the team considered how these variations may impact on their synthesis?○Not applicableCompeting Interests: No competing intere

risk spectrum I confirm that
I have read this submission and believe that I have an appropria e level of expertise to confirm that it is of an acceptable scientific standard.○ Response: Although we acknowledge the importance and the effectiveness of nonpharmacological methods for AOL, this QES will focus on AOL with synthe ic oxytocin infusion.Our intention for the full report is to include a paragraph about other nonpharmacological methods that have demonstrated to be effective in managing prolonged labour (i.e, water immersion).Previous research suggested a potential overuse in clinical practice.Further discussion will be included in the QES.Added:[…] suggesting a potential misuse in clinical practice.○As briefly discussed in the protocol, probably one of the main contributory causes to this disparity is that there is no clear diagnosis criteria for labour dystocia.○[…] the lack of consensus on the diagnostic criteria for labour dystocia has brought into question the robustness of its diagnosis.○Our preliminary findings also suggest the need to improve the indications for AOL.This will be also discussed in our QES.○ ○Negative experiences may also mean traumatic experiences/PTSD a point that asserts the importance of getting labor care right so would add this in.(It also infl

nc
s women to opt out of maternity care altogether, a key point for maternity services to consider).○Response: Yes, birth trauma is an important health problem that needs to be considered when talking about childbirth experiences.Added: 'Moreover, women ○
Women's views and experiences of augmentation of labour with synthetic oxytocin infusion. A protocol for a qualitative evidence synthesis. S Alòs-Pereñíguez, O' Malley, D Daly, D , 10.17605/OSF.IO/2QYJC2021

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